Who should regulate the doctor, health industry relationships?

Professional Council X Legislative Power – who should regulate the relationship between doctors and the health industry?  

CFM Resolution 2,386/2024 aims to regulate the relationship between doctors and the healthcare industry, prioritizing a transparent and trustworthy bond, but faces questions about its legality and practical application.  

On August 21, 2024, the Federal Council of Medicine (CFM) enacted Resolution No. 2,386/2024 , which was approved at a subsequent plenary meeting and published in the Official Gazette of the Union on September 2. The resolution, which will come into effect on March 1, 2025 (article 8), aims to regulate relations between physicians and the healthcare industry (article 1).

Composed of eight articles, the Resolution reveals an essentially simplistic character. It stipulates that any link between doctors and industries must be formally declared by the doctor to the Regional Medical Council (CRM) in which he or she is registered, at the beginning and end of the link (article 2).

The definition of what constitutes a “link” is described in detail in Article 3.

Furthermore, the regulation prohibits physicians from receiving any benefit related to medications, orthoses, prostheses, special materials and hospital equipment not registered with Anvisa, except when these benefits come from research protocols approved by Research Ethics Committees (article 4). Finally, the resolution requires physicians to declare their conflicts of interest in interviews, debates and any presentations intended for the lay public, as well as at medical events (article 6).

Article 5, in turn, presents an apparent narrative flaw: it establishes that “the information referred to in this article must be provided by the beneficiary within 60 (sixty) days after receiving the benefit”, but, paradoxically, article 5 itself does not address any specific content. The interpretation

Despite its relatively concise approach, the resolution seeks to establish ethical guidelines within a command and control system – not surprisingly, conflicts of interest will be disclosed on a dedicated platform by the CFM (sole paragraph of article 2) –, with the aim of ensuring that relations between doctors and the health industry preserve the professional autonomy of the doctor and the quality of care for patients, as highlighted by Rapporteur Councilor Raphael Parente.

Although the rule represents a significant advance in terms of transparency and integrity, its effectiveness is susceptible to questioning due to the lack of robust legal support, as it was enacted by a professional council without the necessary legislative basis.

The debate on regulating relations between doctors and the healthcare industry is not new in Brazil and involves public order issues that require legislative treatment.

At the state level, for example, Minas Gerais has already addressed the issue through specific laws (Laws 22,440/2016 and 22,921/2018), which require the disclosure of relationships between healthcare professionals and the industry, with the information being published on a state platform.

In the federal context, Bills 204/2019 and 7990/2017, which are currently being processed by the National Congress, aim to establish a clear and detailed regulatory framework for these relationships. These bills seek to ensure that all financial relationships between physicians and the industry are publicly disclosed, increasing transparency and minimizing conflicts of interest that could harm public health.

In this scenario, although CFM Resolution 2,386/2024 aims to promote greater transparency in relations between doctors and the healthcare industry, it is important to note the lack of a legal standard to support it, calling into question its legality, in addition to the inherent difficulties of its implementation, such as aspects related to data protection.

The main controversy lies in the competence of professional councils, such as the CFM, to impose new obligations on health professionals in the absence of a specific law granting them this authority. Although the 1988 Federal Constitution assigned to the councils the responsibility of regulating and monitoring the practice of the professions they represent, this power must be exercised within the limits established by current legislation. In this sense, the imposition of obligations, such as the mandatory declaration of employment relationships and the prohibition of receiving certain benefits, can be interpreted as a transgression of these limits, potentially violating the principle of strict legality.

Therefore, the discussion on the Resolution is not limited to the content of the standard published by the CFM, but also focuses on the issue of the regulatory authority of the council to create and implement such regulations without the appropriate legal basis approved by the National Congress. In this context, the attempt to standardize by the CFM, without legislative support, can be considered an extrapolation of its regulatory authority.

This issue is even highlighted by the rapporteur of the resolution when he raises the need for regulation of the matter, comparing the Brazilian scenario with other countries that have specific legislation on the subject, highlighting the “Sunshine Act” in the United States, legislation that has become a global reference. The similarity between the regulations lies in the common objective of increasing transparency and reducing potential conflicts of interest in medical practice. However, CFM Resolution 2,386/2024 arises from a regulatory act of a competent Professional Council without any legislative support, unlike what occurs in the paradigm country. This contrast reveals a significant gap: while internationally recognized legislation has a solid legal basis, the Brazilian resolution still lacks a corresponding legal and legislative basis.

In this context, there is an imminent concern that the rule may be questioned and even challenged in court, which could lead to the suspension of its effects even before it comes into force. There is a latent need for adequate regulation, based on broad legislative debate, highlighting the importance of following due process to ensure the legitimacy and effectiveness of the rules governing the relationship between doctors and the health industry.

Despite the potential recognition of nullity due to the lack of legal basis to support it, CFM Resolution 2,386/2024 should encourage the development of the bills in progress, and even the proposal of new ones on the subject, thus encouraging the creation of an effective, robust and transparent regulatory framework, aligned with the best international and national anti-corruption practices and capable of guaranteeing an environment of trust and ethics in medical practice in Brazil.

Authors:
Bruna B. Rocha, Partner, Life Sciences & Healthcare
Juliana Marcondes de Souza, Associate, Life Sciences & Healthcare
Victoria Cristofaro Martins Leite, Associate, Life Sciences & Healthcare
Camila Dulcine Pessoa de Carvalho, Trainee, Life Sciences & Healthcare

______________________________________________________________________________________

This article describes Campos Mello Advogados’ current thinking on these topics and should not be seen as a legal opinion.

Campos Mello Advogados is a Brazilian law firm that has worked in cooperation with DLA Piper LLP globally since 2010.